Principal CRA - Monitoring Standards & Training at RDI

, , United States -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

115000.0

Posted On

04 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Monitoring, GCP/ICH Guidelines, SDV, Protocol Compliance, Site Management, Mentoring, Training Curricula, Technical Writing, Query Resolution, Deviation Management, ALCOA+, Risk-Based Monitoring

Industry

Hospitals and Health Care

Description

About RDI RDI is an IVD-focused contract research organization. Since 2008 we've run 300+ diagnostic trials for the largest test makers in the world. Our clinical operations team is sharp, motivated, and runs its own workload well — what they need now is someone to raise the ceiling on monitoring craft. About the role This is a senior clinical monitor who teaches. You'll own RDI's clinical-monitoring standard, level up the team by reviewing their real work alongside them, and serve as the senior point of judgment for the hardest monitoring questions. It's a player-coach role — you keep a small live caseload (~25–35%) so your craft stays current and credible, and you spend the rest of your time making everyone around you better. This role requires 3–4 hours of daily overlap with our offshore team UTC+8 (typically early US Pacific morning or late evening). That's the single biggest fit question — confirm it works before you apply. The deliverable isn't visits monitored. It's a team that monitors at a higher standard and operates more independently because of you — and a written, company-owned rubric that outlasts any single study. What you'll do Own the monitoring standard. Build and maintain a living rubric and a library of "what good looks like" — query handling, deviation management, source data review, protocol-compliance judgment — usable in real reviews, not a binder that gets shelved. Teach through real work. Review the team's monitoring side-by-side against the rubric. Most growth happens working through actual files together, not in lectures. Be the senior escalation point. Take on the judgment-heavy monitoring problems above the team's current level, and help the team escalate well — early, scoped, and prepared. Keep a live caseload (~25–35%). Stay hands-on so your craft stays current. Build for independence. Success is the team needing you less over time on competencies you've transferred, so you can move to the next gap. What we're looking for Deep monitoring craft. You've set the bar others were measured against, not just met it — strong SDV/review, protocol-compliance judgment, deviation and query resolution, site management. First-principles command of clinical guidelines. You understand why GCP/ICH (E6, E3, risk-based monitoring) and ALCOA+ exist, not just how to cite them, and you can teach from that understanding. This matters more to us than any specific therapeutic area. A genuine desire to teach. Evidence that you've made other monitors better — mentoring, onboarding, training curricula, co-monitoring, oversight. This is the heart of the role. Writing chops. Your deliverable is a written rubric and library. Plain, precise, usable prose matters. Remote-effective. You collaborate well asynchronously and can hold 3–4 hours of daily overlap with Manila. The right temperament. You earn authority through craft, not title. You're comfortable being a peer-expert to a team that manages itself — you're not looking to manage their workload. A plus, not a requirement: in-vitro diagnostics (IVD) or laboratory experience (clinical chemistry, hematology, immunoassay, molecular dx). We work in this space, but we'd rather hire for monitoring judgment and teaching ability and bring you up to speed on the domain. What this role is not It is not a people-management or workload-coordination role — the team organizes its own work. It is not a desk job removed from the work — you keep monitoring. It is not a "write the SOPs and leave" engagement — the rubric lives through continuous review. It is not a stepping-stone to a Director-of-Monitoring seat — this is the senior IC craft seat. Logistics Remote, US-based, full-time. Must be authorized to work in the US. Base compensation: $100,000–$115,000, commensurate with experience. 3–4 hours of daily overlap with UTC+8 required; otherwise hours are flexible. How we hire We evaluate on real work, not just conversation. Expect a paid hands-on exercise — reviewing and giving feedback on a sample monitoring file — so both sides see the fit clearly before committing. Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k, IRA) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays)

Responsibilities

Establish and maintain the company's clinical monitoring standards and rubrics to improve team independence and quality. Act as a player-coach by managing a small caseload while mentoring and reviewing the work of other monitors.